Man­u­fac­tur­ing prob­lems trig­ger an­oth­er clin­i­cal hold for trou­bled Covid-19 vac­cine — lat­est in a string of road­blocks

Just days af­ter the World Health Or­ga­ni­za­tion sus­pend­ed the use of Co­v­ax­in af­ter a man­u­fac­tur­ing site failed an in­spec­tion, the FDA has fol­lowed up with a clin­i­cal hold on the Covid-19 vac­cine’s US co-de­vel­op­er.

De­tails are in short sup­ply, but the man­u­fac­tur­ing site run by Bharat Biotech in In­dia is at the cen­ter of the is­sue af­ter be­ing cit­ed for “de­fi­cien­cies.” On Tues­day morn­ing, Bharat Biotech’s part­ner Ocu­gen re­port­ed US reg­u­la­tors had placed a hold on the shot’s Phase II/III study. Bharat Biotech de­vel­oped the shot and li­censed it to Ocu­gen to co-de­vel­op it in the US and Cana­da.

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